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FDA 510(k)

Stryker Resorbable Fixation System

K-Number: K231208 · 2023-08-14

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2023-08-14
Product CodeHBW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker Resorbable Fixation System is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2023-08-14 under approval number K231208. The device is classified under product code HBW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Resorbable Fixation System?

Stryker Resorbable Fixation System is a medical device that received FDA 510(k) clearance on 2023-08-14. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K231208.

When was Stryker Resorbable Fixation System approved by the FDA?

Stryker Resorbable Fixation System received FDA 510(k) clearance on 2023-08-14, under approval number K231208.

What company makes Stryker Resorbable Fixation System?

Stryker Resorbable Fixation System is manufactured by Stryker Leibinger GmbH & Co KG.

What is the FDA product code for Stryker Resorbable Fixation System?

The FDA product code for Stryker Resorbable Fixation System is HBW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING

Other Devices by Stryker Leibinger GmbH & Co KG

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Related Devices (Code: HBW)

K171152Stryker Universal Neuro III System AXS ScrewStryker K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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